clinical trial · NCT03824392
Study of Intravenous ATYR1923 (Efzofitimod) for Pulmonary Sarcoidosis
aTyr Pharma, Inc.·phase2·completed·n = 37
Pulmonary SarcoidosisEfzofitimod 1.0 mg/kg or PlaceboEfzofitimod 3.0 mg/kg or PlaceboEfzofitimod 5.0 mg/kg or Placebo
brief summary
This randomized, double-blind, placebo matched to efzofitimod-controlled, study will evaluate the safety, tolerability, immunogenicity, pharmacokinetic (PK), and preliminary efficacy of multiple ascending doses of IV efzofitimod in participants with pulmonary sarcoidosis undergoing a protocol-guided oral corticosteroid (OCS) tapering regimen.This study will consist of 3 staggered multiple dose cohorts. Each eligible participant will participate in only one cohort during the study. Within each cohort, 12 participants will be randomized 2:1 to efzofitimod (N=8) or placebo matched to efzofitimod (N=4).
started
Jan 29, 2019
primary completion
Jun 29, 2021
completion
Jun 29, 2021
last updated
Jul 18, 2023
official title
A Randomized, Double-Blind, Placebo-Controlled Multiple Ascending Dose Study of Intravenous ATYR1923 in Patients With Pulmonary Sarcoidosis
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol